U.S. patent application number 10/991027 was filed with the patent office on 2006-05-18 for multi-functional dispensing spike assembly.
Invention is credited to Cindy Wong.
Application Number | 20060106360 10/991027 |
Document ID | / |
Family ID | 36387371 |
Filed Date | 2006-05-18 |
United States Patent
Application |
20060106360 |
Kind Code |
A1 |
Wong; Cindy |
May 18, 2006 |
Multi-functional dispensing spike assembly
Abstract
A spike assembly for facilitating the supply of a fluid from a
container to a hypodermic syringe, which includes a body having a
first end and a second end, and a fluid conduit extending
therethrough between the first and second ends, a piercing member
located at the first end for piercing into the container to form a
fluid sealing engagement therebetween, the piercing member further
including an inlet means for passing the fluid into the first end
from the container into the fluid conduit, a port configuration
located at the second end for receiving either a needle of the
hypodermic syringe, or a Luer lock inlet port of the syringe, to
enable the hypodermic syringe to draw the fluid from the container
via the fluid conduit, a fluid seal being provided about the
circumference of the needle where it passes into the second end,
and a vent located on the body for venting gas between the ambient
and the interior portion of the container during operation.
Inventors: |
Wong; Cindy; (Monmouth
Junction, NJ) |
Correspondence
Address: |
Kenneth Watov;WATOV & KIPNES, P.C.
P.O. BOX 247
Princeton Junction
NJ
08550
US
|
Family ID: |
36387371 |
Appl. No.: |
10/991027 |
Filed: |
November 17, 2004 |
Current U.S.
Class: |
604/411 |
Current CPC
Class: |
A61J 1/2075 20150501;
A61M 2205/3379 20130101; A61J 1/2096 20130101; A61M 2205/7518
20130101; A61J 1/2013 20150501; A61M 2205/7536 20130101; A61J
1/2082 20150501; A61M 5/162 20130101; A61J 1/201 20150501; A61M
2205/7509 20130101 |
Class at
Publication: |
604/411 |
International
Class: |
A61M 5/32 20060101
A61M005/32 |
Claims
1. A spike assembly for facilitating the supply of a fluid from a
container to a fluid drawing device including a hypodermic syringe,
said spike assembly comprising: a body having a first end and a
second end, and a fluid conduit extending therethrough between the
first and second ends; a piercing member located at the first end
for piercing into the container to form a fluid sealing engagement
therebetween, said piercing member further including means for
passing the fluid into the first end from the container into the
fluid conduit; and means located at the second end for receiving a
fluid port or a needle of the fluid drawing device to enable the
fluid drawing device to draw the fluid from the container via the
fluid conduit, the receiving means providing a fluid seal about the
fluid port where it passes through the receiving means.
2. The spike assembly of claim 1, further comprising means for
communicating to a user details corresponding to the fluid
contained in the container.
3. The spike assembly of claim 1, further comprising means located
on the body for venting a gas between ambient and the interior
portion of the container.
4. The spike assembly of claim 3, wherein the venting means further
comprises a vent extending through the body in fluid communication
with the ambient for facilitating passage of a gas between the
container and the ambient during operation.
5. The spike assembly of claim 4, wherein the vent further
comprises a filter.
6. The spike assembly of claim 4, further comprising means located
on the vent for communicating to a user details corresponding to
the fluid contained in the container.
7. The spike assembly of claim 1, wherein the receiving means is a
Luer lock compatible port.
8. The spike assembly of claim 1, wherein the receiving means
further comprises a resealable membrane port.
9. The spike assembly of claim 8, wherein the resealable membrane
port is in the form of a cap removably mounted to the second end of
the body.
10. The spike assembly of claim 9, wherein the cap and the second
end of the body are reversibly coupled via a Luer lock coupling
engagement.
11. The spike assembly of claim 1, wherein the body further
comprises a flange extending radially therearound for flush
placement on the top of the container during operation.
12. The spike assembly of claim 1, wherein the fluid passing means
further comprises a drain aperture positioned near the point of
entry inside the container, said drain aperture being in fluid
communication with the fluid conduit.
13. The spike assembly of claim 2, wherein the communicating means
further comprises at least one removable band each having
preprinted indicia concealed by a removable cover.
14. The spike assembly of claim 13, wherein the indicia correspond
to a temperature requirement of the fluid.
15. The spike assembly of claim 1, wherein the communicating means
further comprises a plurality of removable concentrically layered
bands each having preprinted indicia.
16. The spike assembly of claim 1, further comprising a retractable
pin extendable from the piercing member.
17. A spike assembly for facilitating the supply of a fluid from a
container to a fluid drawing device including a hypodermic syringe,
said spike assembly comprising: a body having a first end and a
second end, and a fluid conduit extending therethrough between the
first and second ends; a piercing member located at the first end
for piercing into the container to form a fluid sealing engagement
therebetween, said piercing member further including means for
passing the fluid into the first end from the container into the
fluid conduit; means located at the second end for receiving a
fluid port or a needle of the fluid drawing device to enable the
fluid drawing device to draw the fluid from the container via the
fluid conduit, the receiving means providing a fluid seal about the
fluid port where it passes through the receiving means; and means
located on the body for venting gas between ambient and the
interior portion of the container during operation.
18. A spike assembly for facilitating the supply of a fluid from a
container to a fluid drawing device including a hypodermic syringe,
said spike assembly comprising: a body having a first end and a
second end, and a fluid conduit extending therethrough between the
first and second ends; a piercing member located at the first end
for piercing into the container to form a fluid sealing engagement
therebetween, said piercing member further including means for
passing the fluid into the first end from the container into the
fluid conduit; means located at the second end for receiving a
fluid port or a needle of the fluid drawing device to enable the
fluid drawing device to draw the fluid from the container via the
fluid conduit, the receiving means providing a fluid seal about the
fluid port where it passes through the receiving means; and means
for communicating to a user details corresponding to the fluid
contained in the container.
Description
FIELD OF THE INVENTION
[0001] The present invention relates generally to dispensing
device, and more particularly to dispensing spike assembly for
facilitating the drawing of fluid into a syringe from a vial.
BACKGROUND OF THE INVENTION
[0002] One of the most common forms of drug delivery is parenteral
administration, which is typically implemented through the use of a
hypodermic syringe. Certain therapeutic and medicinal agents have
to be administered via a syringe into the blood stream of a
patient. Generally, the therapeutic agents are stored in glass
vials capped with a resealable resilient membrane such as, for
example, a rubber stopper. The hypodermic syringe is composed
generally of a hollow pointed needle, a cylinder defining a
reservoir in communication with the needle, and a plunger slidably
located within the cylinder at the opposite end from the needle.
The plunger is movable to draw into and expel fluid from the
reservoir through the needle. The resealable rubber stopper is
adapted to receive the needle of the syringe and form a fluid seal
around the exterior portion of the needle.
[0003] The steps for directly drawing fluid contents from the vial
into a syringe are well known. More specifically, prior to
inserting the syringe into the vial, the plunger is drawn back to
draw air into the syringe until the tip of the plunger reaches the
line of the number of units required. The rubber stopper of the
vial is wiped with an antiseptic. With the vial maintained in an
upright position, the syringe needle is then pushed through the
rubber stopper. The plunger is then pressed to expel the air into
the vial. The vial and syringe is upturned bottom side up with the
needle in the fluid. The syringe plunger is drawn back until it is
at the appropriate line for the dose needed.
[0004] One problem in the prior art is that when a needle must be
inserted into a vial to load the syringe with the fluid, in
applications where a plurality of doses are obtained from the same
vial, it is very difficult to avoid wasting a portion of the
medication. When the fluid reaches a critical level, the user must
often maneuver the needle tip below the fluid level to catch the
fluid. Otherwise, the vial is typically discarded with a portion of
the fluid still present, thus resulting in waste. A further problem
is the use of needles to withdraw fluid from a container, which
increases the likelihood of accidents involving inadvertent
pricking. Another problem in the prior art is that vials filled
with medication must be kept or stored within specific temperature
ranges such as, for example, room temperature or refrigeration
temperature. It is important that the health care provider be
provided a readily observable notice as to storage requirements for
a vial of medication after dispensing to a syringe.
[0005] Yet another problem requiring solution is to provide users
of vials containing multiple doses of medication, for example, a
way to maintain an indication of the original starting level of the
medication or fluid, with the vial upright, before a first dose is
withdrawn, to "eyeball" how many doses remain after each dose
drawing.
[0006] Accordingly, there is a need for a spike assembly that can
be operatively engaged to a fluid-containing vial in a manner,
which effectively minimizes or eliminates the problems associated
with prior art dispensing methods. There is a further need for a
spike assembly that enhances the relative ease and promptness of
dispensing fluids for drawing into a hypodermic syringe, while
substantially minimizing waste and contamination of the fluid, and
providing a readily observable notice of storage requirements
and/or light sensitivity precautions. There is a further need to
design a spike assembly having a removable port adapted to receive
a hypodermic needle, which permits compatible use of the spike
assembly with syringes outfitted with or without a hypodermic
needle.
SUMMARY OF THE INVENTION
[0007] The present invention relates generally to a spike assembly
useful for facilitating the dispensing of a fluid (typically a
medication) from a vial to a fluid passing device such as a
hypodermic syringe, maintaining the proper storage temperature
and/or light sensitivity of the vial, reducing accidental needle
pricking, and minimizing waste of the fluid. Typically, the vial
includes a self sealing resilient membrane such as, for example, a
rubber stopper, through which the spike assembly accesses the
fluid. The spike assembly is adapted to be fluidly coupled with a
fluid containing vial to form a fluid sealing engagement
therebetween, thereby preventing or at least substantially
minimizing undesirable leakage and contamination. The spike
assembly includes a fluid conduit adapted to receive the needle or
fluid port of a hypodermic syringe at one end, and at the other end
for drawing fluid from the vial into the conduit therefrom into the
needle or fluid port, rapidly and conveniently. Alternatively, the
spike assembly can include a Luer lock fitting for coupling
directly to a Luer lock port fitting of a syringe in the absence of
a needle. The spike assembly of the present invention enhances the
relative ease and promptness of dispensing fluids from a vial into
a hypodermic syringe and promptly identifying the contents of a
container, while substantially minimizing accidental needle prick,
and reducing waste and contamination of the fluid.
[0008] The spike assembly of the present invention generally
includes a body having an open first end, a second end, and a fluid
conduit extending between the first and second ends. The first end
includes a piercing member designed to puncture through the
resilient membrane of the vial to gain access to the fluid
contained in the vial. Once accessed, the vial can be turned or
rotated bottom up to cause the fluid to enter the fluid conduit
through the open first end of the spike assembly. The second end
may be operated either in an open state or in a closed state. In
the closed state, the second end is adapted to receive the needle
of the hypodermic syringe where a fluid seal is formed around the
received needle to prevent leakage during dispensing from the fluid
conduit. In the open state, the second end is adapted to receive a
needleless syringe for fluid coupling therebetween.
[0009] With the vial rotated to an upturned vertical position, the
fluid in the vial enters the fluid conduit in contact with the
needle. As the plunger of the syringe is drawn back to a desired
dosage mark, the fluid is drawn from the fluid conduit via the
needle into the syringe.
[0010] In one aspect of the present invention, there is provided a
spike assembly for facilitating the supply of a fluid from a
container to a fluid drawing device including a hypodermic syringe,
the spike assembly comprising:
[0011] a body having a first end and a second end, and a fluid
conduit extending therethrough between the first and second
ends;
[0012] a piercing member located at the first end for piercing into
the container to form a fluid sealing engagement therebetween, the
piercing member further including means for passing the fluid into
the first end from the container into the fluid conduit; and
[0013] means located at the second end for receiving a fluid port
or a needle of the fluid drawing device to enable the fluid drawing
device to be operated to draw the fluid from the container via the
fluid conduit, the receiving means providing a fluid seal about the
fluid port or the needle where it passes through the receiving
means.
[0014] In another aspect of the present invention, there is
provided a spike assembly for facilitating the supply of a fluid
from a container to a fluid drawing device including a hypodermic
syringe, the spike assembly comprising:
[0015] a body having a first end and a second end, and a fluid
conduit extending therethrough between the first and second
ends;
[0016] a piercing member located at the first end for piercing into
the container to form a fluid sealing engagement therebetween, the
piercing member further including means for passing the fluid into
the first end from the container into the fluid conduit;
[0017] means located at the second end for receiving a fluid port
or a needle of the fluid drawing device to enable the fluid drawing
device to draw the fluid from the container via the fluid conduit,
the receiving means providing a fluid seal about the fluid port or
the needle where it passes through the receiving means; and
[0018] means located on the body for venting gas between ambient
and the interior portion of the container during operation.
[0019] In a further embodiment of the present invention, the spike
assembly may further include means for selectively indicating
storage requirements including temperature and/or light sensitivity
for the fluid or medication contained in the container.
[0020] Optionally, the spike assembly of the present invention may
further include a drain aperture positioned near the point of entry
inside the container, said drain aperture being in fluid
communication with the fluid conduit.
BRIEF DESCRIPTION OF THE DRAWINGS
[0021] Various embodiments of the invention are described in detail
below with reference to the drawings, in which like items are
identified by the same reference designations, wherein:
[0022] FIG. 1 is a perspective view of a spike assembly mounted on
a fluid medication containing vial for various embodiments of the
present invention;
[0023] FIG. 2 is a perspective view of the spike assembly with the
interior portions thereof drawn in phantom for various embodiments
of the present invention;
[0024] FIG. 3 is a perspective view of a spike assembly shown with
a different visual cue component than the embodiment of FIGS. 1 and
2 for an alternative embodiment of the present invention;
[0025] FIG. 4 is a top plan view of the spike assembly of FIG. 1 in
accordance with the present invention;
[0026] FIG. 5 is a side partial cross sectional view of the spike
assembly taken along lines 5-5 of FIG. 4 in accordance with various
embodiments of the present invention;
[0027] FIG. 6 is an enlarged perspective view of a top portion of
the spike assembly of FIG. 1;
[0028] FIG. 7 is a perspective view of a spike assembly using a
Luer lock type fitting for another embodiment of the present
invention;
[0029] FIG. 7A is a bottom plan view of the spike assembly of FIG.
7;
[0030] FIG. 8 is an assembly view of a port structure of a spike
assembly for another embodiment of the present invention;
[0031] FIG. 9 is a cross sectional view of the port structure with
the port member secured to the open extension in accordance with
the present invention;
[0032] FIG. 10 is a cross sectional view of the port structure with
the port member shown unsecured from the open extension in
accordance with the present invention;
[0033] FIG. 11 is a perspective view of the open extension of the
spike assembly; and
[0034] FIG. 12 is a perspective view of the open extension rotated
90.degree. about its vertical axis in accordance with the present
invention.
DETAILED DESCRIPTION OF THE INVENTION
[0035] The present invention is directed to a spike assembly
adapted for facilitating the dispensing of fluids, typically a
medication, from a fluid container or a vial into syringes or other
fluid drawing devices. The spike assembly provides protection
against inadvertent spillage or fluid leakage from the vial during
dispensing and storage. The spike assembly of the present invention
is adapted to form a sealing engagement with the vial to maintain
the fluid content in a sterile germ free condition, while enhancing
the ease at which the fluid is dispensed into the syringe. The
spike assembly of the present invention further functions to
minimize introduction of potential contaminants into the vial being
dispensed and reduces waste of the fluid.
[0036] The spike assembly is designed to be compatible for use with
needle and needleless syringes or other fluid drawing devices.
Accordingly, when used in conjunction with a needleless fluid
drawing device (e.g., hypodermic syringe without needle attached),
the spike assembly advantageously eliminates the probability of
accidental or inadvertent pricking or jabbing during dispensing
that may imperil the health and safety of the user.
[0037] The spike assembly can further be adapted to allow the user
to readily identify the contents and/or storage temperature, and/or
provide an indication of light sensitivity of the fluid to be
dispensed by including a visual marker(s) or indicator(s) that can
be easily implemented by the user. In this manner, the user can
simply glance at the visual marker(s) without having to read the
label directly affixed on the vial. The present spike assembly, in
its various embodiments, is simple and cost effective to make using
existing fabrication techniques as known in the art, and can be
fabricated in a disposable form, thus making it especially suitable
for use in the medical and pharmaceutical industry.
[0038] The spike assembly of the present invention generally
includes a body having a first end and a second end, and a fluid
conduit extending therethrough between the first and second ends.
The spike assembly further includes a piercing member located at
the first end for piercing into the vial to form a fluid sealing
engagement therebetween, wherein the piercing member further
includes means for passing the fluid into the first end from the
vial into the fluid conduit, and means located at the second end
for receiving a fluid port or a needle of the hypodermic syringe to
enable the hypodermic syringe to draw the fluid from the vial via
the fluid conduit, the receiving means providing a fluid seal about
the fluid port or the needle where it passes through the receiving
means.
[0039] With reference to FIG. 1 of the drawings, a spike assembly
generally identified by reference numeral 10 is shown for multiple
embodiments of the present invention. The spike assembly 10 is
designed for coupling with a vial 12 containing a fluid 15 such as,
for example, a therapeutic agent. The vial 12 includes a cap 14
that seals the fluid 15, such as, for example, a medication. The
cap 14 of the vial 12 may be composed of a metal foil such as, for
example, plastic, aluminum or a resilient resealable material such
as rubber. The spike assembly 10 includes a body 16 having a top
end 18 and a bottom end 20, and an optional vent member 22 for
allowing gas to pass between the vial 12 and the ambient as will be
further described hereinafter.
[0040] The spike assembly 10 can be composed of any suitable rigid
material that is at least substantially inert to fluids especially
pharmaceutically active agents and the like. The rigid inert
material includes plastics, metals, glass and the like. The spike
assembly 10 can be fabricated from multiple component parts. It is
preferable that the main body of the spike assembly be composed of
a single, unitary construction, such as obtained via molded plastic
material, for example.
[0041] The bottom end 20 includes a piercing portion 24 adapted for
piercing through the cap 14. The piercing portion 24 comprises a
steeply angled tapered shape that forms a sharp piecing tip. Upon
piercing, the piercing portion 24 penetrates through the cap 14 and
occupies the interior portion of the vial 12. A flange portion 26
extends around a midportion of the body 16 below the vent member
22, and maintains a flush contact with the top of the vial 12
during coupling engagement. The flange portion 26 ensures that the
spike assembly 10 is positioned at a sufficient depth into the vial
12, while minimizing undesirable shifting of the spike assembly 10
in the vial 12 during usage. A drain aperture 28 is located
proximate the flange portion 26 on the piercing portion 24 near its
entry into the vial 12, as shown, for maximizing the amount of
fluid withdrawn from the vial 12 into the fluid conduit 46.
[0042] The top end 18 includes an opening 30 having an internal
threaded portion 32. A port or cap member 34 having an external
threaded portion 36 is adapted for sealing engagement with the
opening 30, and is secured by the threaded engagement between the
threaded portions 32 and 36 of the opening 30 and the port member
34, respectively. The port member 34 and the opening 30, in
combination, form a port structure 80. The port member 34 ensures
that the spike assembly 10 remains fluidly sealed to prevent fluid
leakage or passage from the vial 12. The port member 34 includes a
resealable membrane portion 35 that allows the needle of a
hypodermic syringe to be inserted therethrough and sealed about its
entry point to enable fluid 15 to be drawn from the vial 14 as will
be further described below. It is noted that the port member 34 and
the opening 30 can be adapted to include any fluid coupling
configurations as known in the art such as, for example, Luer lock
coupling configurations, and the like which allows compatible fluid
coupling with various fluid passing devices including those having
attached needles or those without needles. It is further noted that
the port member 34 can be formed as an integral component
permanently affixed to the body 16 of the spike assembly 10.
[0043] Optionally, the spike assembly 10 can further include a
metering pin 38 slidably extendable from the piercing portion 24.
The metering pin 38 located within a channel groove 40 includes a
small protruding handle portion 42, which can be pushed vertically
upward or downward by a user along the outside of the spike
assembly 10. Such action causes, the proximal end of the pin 38 to
be slidably moved in a vertical direction along the channel groove
40 by the user to actuate the extension or retraction of the
metering pin 38 within the vial 12. The operation of the metering
pin 38 will be further explained hereinafter.
[0044] In one preferred embodiment, the spike assembly 10 further
includes a visual indicator 44 composed of a plurality of indicator
portions 45 each covered by a strip 44a, 44b or 44c. The indicator
portions 45 each can be preprinted with a preassigned color coding
and/or indicia, which represent to the user information such as
details of the contents of the vial 12, including storage
temperature requirements, and/or light sensitivity. One or more
specific indicator portions 45 can be selectively revealed by
removing one corresponding strip 44a, 44b or 44c depending on the
desired indicia and/or color(s) to be revealed. In the preferred
embodiment, the indicator portions 45 are used to provide
information about storage condition requirements, for example, blue
representing refrigeration, yellow representing room temperature or
a cool place, and orange representing light sensitivity. Note that
the invention is not limited to any particular color or indicia for
providing desired visual information.
[0045] Referring to FIG. 2, the spike assembly 10 includes a fluid
conduit 46 that extends between the opening 32 and an inlet 47 at
the bottom end 20. The drain aperture 28 is positioned in fluid
communication with the fluid conduit 46. The fluid conduit 46 is
configured to facilitate the flow of fluid 15 from the bottom end
20 to the top end 18 of the spike assembly 10. In this manner, a
needle of a hypodermic syringe upon insertion into the port member
34 is positioned within the fluid conduit 46 to permitting drawing
of the fluid 15 therefrom into an associated syringe. The drain
aperture 28 is positioned proximate to the flange portion 26 to
permit fluid 15 to drain substantially fully from the vial 12
during operation (i.e., drawing by the syringe) as will be further
described hereinafter.
[0046] The spike assembly 10 further includes an air conduit 52
extending at least between an inlet 48 of the vent member 22 and an
outlet 53 located at the bottom end 20 of the air conduit 52. The
air conduit 52 allows the passing of ambient air through the inlet
48, a filtering medium 48a retained in vent member 22 (as shown
best in FIG. 5), a vent outlet 29, the air conduit 52, and through
the vent outlet 53 into the vial 12, during the dispensing of the
fluid 15 as it is drawn into the syringe. The filtering member 22
further includes a check valve mechanism 50 located between the
filter inlet 48 and the air conduit 52. The check valve mechanism
50 operates to allow a one way flow of air from the filter inlet 48
into the vial 12, while preventing passage of the fluid 15 and air
in the opposite direction. The check valve mechanism 50 can
encompass any one way types valves as known in the art including,
for example, ball check valves. This permits the equalization of
air pressure between the syringe being filled and the vial 12.
[0047] As best shown in FIG. 2, the top portion of the channel
groove 40 includes an open slot 41 that extends along the side of
the spike assembly 10 to the flange portion 26 and terminates at a
resilient grommet 54. The handle portion 42 is slidably movable by
the user through the length of the open slot 41. The metering pin
38 is positioned within the channel groove 40 and extends through a
pin opening 39 at the bottom end 20 of the spike assembly 10. The
user can move the metering pin through the pin opening by operating
the handle portion 42. The resilient grommet 54 cooperates with the
external surface of the metering pin 38 to ensure a good fluid seal
to prevent passing of the fluid 15 from the vial 12 into the open
slot 41. The interaction between the resilient grommet 54 and the
metering pin 38 provides sufficient frictional force to prevent
inadvertent movement once the metering pin 38 is set at a specific
position.
[0048] Referring to FIG. 3, an alternative embodiment of the spike
assembly 10 is shown. The spike assembly 10 includes all the
component parts except the visual indicator 44 shown in FIGS. 1 and
2. The spike assembly 10 includes a visual indicator 57 having a
single band 58 composed of a plurality of concentrically arranged
strips 56. Each of the strips 56 includes different indicia or
color scheme representing specific information, for example, as to
the content of the vial 12 or a specific storage requirement, such
as, for example, temperature range. As an example using a color
scheme, blue may signify refrigeration, yellow may signify a room
temperature or cool storage, and orange may signify light
sensitive. The user can remove each of the concentric strips 56
until the strip 56 containing the desired indicia is exposed.
[0049] Referring to FIGS. 4 and 6, the port member 34 can be
threadedly removed from the opening 30 in the event the user needs
to dispense the fluid 15 directly from the vial 12 in any known,
conventional manner. Alternatively, the port member 34 can be
readily replaced with a suitable fluid connector such as, for
example, an intravenous drip connector for facilitating continuous
dispensing as desired. In addition, the visual indicator 44 is
preferably positioned at an appropriate location on the spike
assembly 10 to enable the user to see it from various angles.
[0050] Referring to FIG. 5, a cross sectional view of the spike
assembly 10 is shown. The filtering medium 48a in vent 22 is
generally composed of a mechanical filter preferably of the type
have a pore size that is sufficiently small to prevent passage of
undesirable contaminants including, but not limited to, pathogens,
bacteria, dust, spores, mold, viruses, dirt, and the like. The
filtering medium 48a may further include other filter materials
that are chemically active such as activated charcoal materials or
desiccants that can further prevent other undesirable contaminants
from entering the spike assembly 10 and ultimately into the vial
15. The fluid conduit 46 and the air conduit 52 are preferable
arranged separately and at a distance from one another to prevent
unintentional drawing of the air along with the fluid 15 to be
dispensed.
[0051] The metering pin 38 can be extended or retracted through the
pin opening 39 by moving the handle portion 42. The metering pin 38
assists the user by providing a visual cue as a full volume marker.
This feature allows the user to visually estimate to the number of
doses or volume of the fluid 15 remaining within the vial 12. The
metering pin 38 allows the using to mark the initial volume of the
fluid 15. During operation, the end of the metering pin 38 is
extended down to the full volume level of the fluid 15 with the
vial 12 in the upright position. Once the meter pin 38 is set at
the full volume mark, it remains in the same position. The user
draws the fluid 15 by the hypodermic syringe in the usual manner,
until the desired dosage is obtained. The user returns the vial 12
to the upright position and thus is able to visually determine the
volume or number dosages of the fluid 15 is remaining by comparing
the full volume position of metering pin 38 with the current level
of the fluid 15 in the vial 12. Accordingly, the user can estimate
visually how much volume is remaining in the vial 12 for greater
inventory prediction.
[0052] Referring to FIG. 7, a spike assembly 70 is shown for
another embodiment of the present invention. The spike assembly 70
includes the same components as the spike assembly 10 of FIG. 2
except for a different configuration for a port member 72 and an
opening 62, and for a piecing portion 60, in addition, to the
absence of a metering pin 38. The port member 72 and the opening
62, in combination, form a port structure 82 at the top end 18. The
port member 72 comprises a tapered fitting for coupling with the
corresponding tapered opening 62 to produce a snug sealing fit
therebetween. The port member 72 further comprises a circular
protrusion 74 which is configured to be seated within a
corresponding circular groove 76 of the opening 62 to form a fluid
seal fit therebetween. The tapered opening 62 in adapted to receive
a standard syringe having a similarly tapered fluid port to permit
the syringe to be filled with medication in the absence of an
attached needle. Note also that the configuration of the port
structure 82 shown herein can be interchanged with the port
structure 80 of FIGS. 1 to 6. In addition, the piercing portion 60
of the spike assembly 70 can also be interchanged with the piercing
portion 24 of FIGS. 1 to 6.
[0053] Referring to FIG. 7A, a bottom plan view of the spike
assembly 70 is shown. The inlet 47 of the fluid conduit 46 and the
outlet 53 of the air conduit 52 are located at opposing sections of
the piercing portion 60.
[0054] Referring to FIG. 8, a port structure 84 located at the top
end 18 of a spike assembly 200 is shown for another embodiment of
the present invention. The port structure 84 includes a Luer lock
construction for enabling fluid coupling with Luer lock type
syringes or other similarly configured fluid drawing devices. The
port structure 84 includes a port member 86 having an upper portion
88 and a lower portion 90, and an open extension 92 with a pair of
locking tabs 96 and an opening 98 in fluid communication with the
fluid conduit 46. The upper portion 88 is composed of a resilient
material such as rubber, and the lower portion 90 is composed of a
rigid material. The port structure 84 is adapted to facilitate
fluid coupling with hypodermic syringes with or without an attached
needle.
[0055] The port member 86 is adapted for Luer lock fluid coupling
engagement with the open extension 92. The port member 86 is
adapted to permit the needle of a hypodermic syringe to be passed
into the open extension 92 for dispensing fluid through the spike
assembly 200. Alternatively, the port member 86 can be removed from
the open extension 92 for coupling with a hypodermic syringe
without an attached needle. The open extension 92 is adapted to
fluidly couple with a corresponding Luer lock configured fluid port
of a needleless syringe (not shown) to permit dispensing of the
fluid through the spike assembly 200. It is noted that the open
extension 92 is further adapted to receive a standard syringe
having a typical "slip fit" fluid port for fluid coupling.
[0056] Referring to FIGS. 9 through 12, the port member 86 includes
a central top cavity 100, a membrane portion 102, and central
bottom cavity 106 with internal threads 104. The central bottom
cavity 106 is adapted to reversibly receive the open extension 92
for engagement therebetween and seal in the opening 98 of the
extension 92 from ambient. The internal threads 104 are adapted to
threadedly engage the locking tabs 96 of the open extension 92. The
port member 86 is securable to open extension 92 with the twist of
a turn clockwise to engage the locking tabs 96 with the threads
104. The locked engagement between the locking tabs 96 and the
threads 104 biases the upper portion 88 of the port member 86
against the top edge portion of the open extension 92 to produce a
fluid seal, thereby preventing any fluid leakage. With the port
member 86 coupled to the extension 92, a hypodermic needle can be
passed through the central cavity 100 and pierced through the
membrane portion 102 into the opening 98. The resilient membrane
portion 102 is composed of a resilient material that allows a
hypodermic needle to penetrate it, while maintaining a fluid seal
during and after dispensing.
[0057] With reference to FIGS. 1, 2, 4, and 5 through 12, the
operation of the spike assembly will now be described in general.
The spike assembly 10 can be fabricated in a form suitable for
disposable one time use in order to ensure sterility and minimize
contamination during use. The rubber cap 14 of the vial 12 is wiped
with an antiseptic. The spike assembly 10 is thereafter mounted to
the vial 12 by pushing the piercing portion 24 through the cap 14
of the vial 12 until the flange portion 26 comes into contacts with
the cap 14. Optionally, the user may operate the metering pin 38 by
moving the handle portion 42 downward until the tip the metering
pin 38 into contact with the surface of the fluid 15. Once set, the
metering pin 38 is maintained statically in position through
frictional interaction between the metering pin 38 and the grommet
54.
[0058] The user thereafter obtains a clean and sterile hypodermic
syringe. The port member 35 may be removed to allow the spike
assembly 10 to receive the fluid port of the hypodermic syringe
without an attached needle. Otherwise the port member 35 remains
coupled to the opening 30 and the hypodermic needle of the syringe
may be inserted through the resilient resealable membrane portion
35 of the port member 34. The vial 12, the spike assembly 10 and
the hypodermic syringe are then upturned bottom side up to allow
the fluid 15 to fill the fluid conduit 46 of the spike assembly 10.
The syringe plunger is then drawn back until the appropriate line
for the dosage is reached. If the piercing portion 24 is above
fluid level (i.e., low fluid level), the fluid 15 is simply drained
through the drain aperture 28 into the fluid conduit 46 to minimize
waste and avoid the need to manipulate the needle within the vial
15 to get at the fluid 15.
[0059] For needleless syringes, the port member 34 is removed from
the opening 30 to receive the fluid port of the syringe.
Thereafter, the fluid is dispensed from the vial 12 in the same
manner as described above.
[0060] Alternatively, as previously mentioned relative to the
embodiment of FIG. 7, if the needleless syringe has a tapered fluid
port without a needle attached thereto, it can be directly coupled
with the spike assembly 10 at the tapered opening 30 (see FIG. 7)
for drawing fluid. For use with a needle equipped syringe, the port
member 72 can be replaced in the opening 30 with the needle
inserted the through a resealable membrane portion 35 into the
fluid conduit 46 for withdrawing fluid therefrom.
[0061] Alternatively, as previously mentioned relative to the
embodiment of FIG. 8, if the needleless syringe has a Luer lock
fluid port without a needle attached thereto, it can be directly
coupled with the spike assembly 10 at the corresponding Luer lock
open extension 92 (see FIG. 8) for drawing fluid. For use with a
needle equipped syringe, the port member 86 can be coupled with the
open extension 92 with the needle inserted the through sealable
membrane portion 88 via the cavity 100 into the fluid conduit 46
for withdrawing fluid therefrom.
[0062] As the fluid is drawn into the syringe, ambient air is drawn
through the filter member 22 to take up the vacuum in the vial 12
generated by the syringe. Upon completion of the dispensing, the
syringe can then be withdrawn from the vial 12. The vial 12 and
spike assembly 10 are returned to a suitable storage area in the
upright position. Optionally, the user may check the metering pin
38 to visually determine the volume dispensed.
[0063] Although various embodiments of the invention have been
shown and described, they are not meant to be limiting. Those of
skill in the art may recognize various modifications to these
embodiments, which modifications are meant to be covered by the
spirit and scope of the appended claims. For example, the present
invention is not limited to vials, but can also be utilized with
intravenous bags, and the like.
* * * * *